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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Testosterone Compounded Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: July 24, 2023
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Summary

New Vitalis Pharmacy is voluntarily recalling 102 vials of compounded Testosterone Cypionate-Testosterone Propionate (180-20 mg/mL) injectable medication due to a lack of assurance of sterility. The recall includes both 1 mL and 5 mL multi-dose vials in cottonseed oil intended for intramuscular use. Because these products are injected, any compromise in sterility could lead to serious infections.

Risk

Injectable medications that are not sterile can introduce bacteria or other contaminants directly into the body, potentially causing severe infections. No injuries or adverse reactions have been reported to date for this recall.

What You Should Do

  1. The recalled products are compounded Testosterone Cypionate-Testosterone Propionate (180-20 mg/mL) injections in cottonseed oil sold in 1 mL vials and 5 mL multi-dose vials.
  2. Check your medication for lot numbers AL-05222023@901 (Use By 7/22/23), AL-06122023@908CS (Use By 8/11/23), or AL-05222023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact New Vitalis Pharmacy at 4139 Cadillac Ct, Ste 201, Louisville, KY 40213 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone Cypionate-Testosterone Propionate (180-20 mg/mL) in cottonseed oil
Variants: 1 mL Vial, 5 mL Multi-Dose Vial, Compounded Rx
Lot Numbers:
AL-05222023@901 (BUD 7/22/23)
AL-06122023@908CS (BUD 8/11/23)
AL-05222023

Recall #: D-0944-2023. For Intramuscular Use Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92699
Status: Active
Manufacturer: New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Sold By: New Vitalis Pharmacy
Manufactured In: United States
Units Affected: 102 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.